Foot Ulcer, DiabeticNCT06023810
The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers
A study testing Watson's human care theory-based motivational interviewing method in people with Foot Ulcer, Diabetic, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Watson's human care theory-based motivational interviewing method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with clear consciousness,
- No communication problems,
- Diagnosed with type 1 or type 2 diabetes,
- Grade 1 diabetic foot ulcer according to the Wagner classification,
- Receiving standard wound care,
- Residing in the Kocaeli province,
- No musculoskeletal or neurological disorders that could interfere with the study,
- Individuals willing to participate and who sign the informed consent form.
Who cannot join
- Patients who do not meet the inclusion criteria and those who decline to participate in the study will not be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Training and Research Hospital
Kocaeli
About this study
Official title: The Effect of Watson's Human Care Theory-Based Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers: A Randomized Controlled Trial
The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Given this context, there is a clear necessity for interventions that motivate patients to adopt beneficial health behaviors and educate them in effectively managing diabetes-related complications. This study seeks to investigate the impact of Watson's motivational interviewing method, which is grounded in the human care theory, on enhancing treatment adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic foot ulcers.
Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education, and those who receive standard education.
Read more
H1: There is a difference in self-efficacy for diabetic foot care between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H2: There is a difference in diabetic foot care behavior between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H3: There is a difference in treatment adherence between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
Read the detailed description
According to the International Diabetes Federation (IDF) data, there are currently 425 million adults worldwide affected by diabetes, and it is projected to increase to 578 million by 2030 and 700 million by 2045. The increasing prevalence of diabetes has led to a rise in the frequency of complications arising from diabetes. The escalation in diabetes complications and their consequences is concerning. There is a need for interventions that encourage positive changes in health behaviors among patients and teach better management of diabetes-related complications.
Diabetic foot ulcer, a challenging complication of diabetes, has significant effects on physical, mental, social, and economic well-being, leading to reduced quality of life. It often necessitates prolonged hospitalizations, intensive treatment, and high medical costs. One of the nursing models frequently preferred today is the Human Care Theory, developed by Jean Watson between 1975 and 1979. The Human Care Theory is centered around providing quality care to patients and maintaining effective communication. Motivational Interviewing is a counseling approach developed by clinical psychologists William R. Miller and Stephen Rollnick.
The aim of the study is to investigate the impact of Watson's human care theory-based motivational interviewing method on treatment adherence, self-efficacy, and satisfaction in individuals with diabetic foot ulcers. In this study, a randomized controlled experimental-control group experimental design will be used. The population of the study consists of patients who applied to Kocaeli Derince Training and Research Hospital Internal Medicine outpatient clinics between June and October 2023, diagnosed with type 1 and type 2 diabetes mellitus, with first degree diabetic foot wound according to the Wagner classification. With the power analysis program G-Power 3.1.9.2, the sample size was calculated as 38 people (76) in each group.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Watson's human care theory-based motivational interviewing method
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watson's human care theory-based motivational interviewing methodBehavioural
Also called Pre-post test
The Motivational Interviewing Program based on Watson's Theory of Human Caring will be conducted over an 8-week period, with sessions taking place once a week. The initial session will have a duration of 60 minutes, while the subsequent weekly sessions will last for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Watson's human care theory-based motivational interviewing method Receives: Behavioral: Watson's human care theory-based motivational interviewing method |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wagner's ulcer classification scale
The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
Measured: at 1 week
Wagner's ulcer classification scale
The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
Measured: at 8 weeks
Wagner's ulcer classification scale
The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
Measured: at 12 weeks
Secondary outcomes (7)
Diabetic Foot Care Self-Efficacy Scale
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Measured: at 1 week
Diabetic Foot Care Self-Efficacy Scale
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Measured: at 8 weeks
Diabetic Foot Care Self-Efficacy Scale
It was developed to assess individuals' perception of their ability to perform diabetic foot care activities. The lowest score obtainable from the scale is 0, and the highest is 90. An increase in scale score indicates a higher level of individual self-efficacy.
Measured: at 12 weeks
Medication Adherence Report Scale
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Measured: at 1 week
Medication Adherence Report Scale
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Measured: at 8 weeks
Medication Adherence Report Scale
The scale consists of 5 items rated on a 5-point Likert scale. Scores obtained from the items are summed to calculate the total test score. An increase in the total score obtained from the scale indicates agreement, while a decrease indicates disagreement
Measured: at 12 weeks
Watson Patient Satisfaction Assessment Form According to Healing Processes
The form consists of a total of six questions. The first five questions are scored on a scale of 1 to 7, with responses ranging from 'never' (1) to 'always' (7).
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Mar 2023
- Primary completion1 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sakarya University
- Responsible party
- Principal investigator, Nida Efetürk, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023810
- Sponsor's protocol ID
- IstanbulOkanU-N-EFETURK-001
- Status last verified
- Nov 2025
- First submitted
- 10 Aug 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Watson's Human Care Theory-Based Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06023810
- Acronym / sponsor ID
- IstanbulOkanU-N-EFETURK-001
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Sakarya University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Given this context, there is a clear necessity for interventions that motivate patients to adopt beneficial health behaviors and educate them in effectively managing diabetes-related complications. This study seeks to investigate the impact of Watson's motivational interviewing method, which is grounded in the human care theory, on enhancing treatment adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic foot ulcers.
Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education, and those who receive standard education.
H1: There is a difference in self-efficacy for diabetic foot care between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H2: There is a difference in diabetic foot care behavior between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H3: There is a difference in treatment adherence between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
Detailed description
According to the International Diabetes Federation (IDF) data, there are currently 425 million adults worldwide affected by diabetes, and it is projected to increase to 578 million by 2030 and 700 million by 2045. The increasing prevalence of diabetes has led to a rise in the frequency of complications arising from diabetes. The escalation in diabetes complications and their consequences is concerning. There is a need for interventions that encourage positive changes in health behaviors among patients and teach better management of diabetes-related complications.
Diabetic foot ulcer, a challenging complication of diabetes, has significant effects on physical, mental, social, and economic well-being, leading to reduced quality of life. It often necessitates prolonged hospitalizations, intensive treatment, and high medical costs. One of the nursing models frequently preferred today is the Human Care Theory, developed by Jean Watson between 1975 and 1979. The Human Care Theory is centered around providing quality care to patients and maintaining effective communication. Motivational Interviewing is a counseling approach developed by clinical psychologists William R. Miller and Stephen Rollnick.
The aim of the study is to investigate the impact of Watson's human care theory-based motivational interviewing method on treatment adherence, self-efficacy, and satisfaction in individuals with diabetic foot ulcers. In this study, a randomized controlled experimental-control group experimental design will be used. The population of the study consists of patients who applied to Kocaeli Derince Training and Research Hospital Internal Medicine outpatient clinics between June and October 2023, diagnosed with type 1 and type 2 diabetes mellitus, with first degree diabetic foot wound according to the Wagner classification. With the power analysis program G-Power 3.1.9.2, the sample size was calculated as 38 people (76) in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Watson's human care theory-based motivational interviewing methodWatson's human care theory-based motivational interviewing method |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals with clear consciousness,
- No communication problems,
- Diagnosed with type 1 or type 2 diabetes,
- Grade 1 diabetic foot ulcer according to the Wagner classification,
- Receiving standard wound care,
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria and those who decline to participate in the study will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watson's human care theory-based motivational interviewing methodAlso: Pre-post testThe Motivational Interviewing Program based on Watson's Theory of Human Caring will be conducted over an 8-week period, with sessions taking place once a week. The initial session will have a duration of 60 minutes, while the subsequent weekly sessions will last for 30 minutes | Behavioural | experimental |
Primary outcome
Wagner's ulcer classification scale
Time frame: at 1 week
The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
Wagner's ulcer classification scale
Time frame: at 8 weeks
The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
Wagner's ulcer classification scale
Time frame: at 12 weeks
The Wagner classification divides ulcers based on the depth of the wound and the extent of gangrene. Grade 0, Skin intact but bony deformities lead to "foot at risk"; Grade 1, Superficial ulcer; Grade 2, Deeper, full thickness extension; Grade 3, Deep abscess formation or osteomyelitis; Grade 4, Partial Gangrene of forefoot; Grade 5; Extensive Gangrene.
7 secondary outcomes
Diabetic Foot Care Self-Efficacy Scale
Time frame: at 1 week
Diabetic Foot Care Self-Efficacy Scale
Time frame: at 8 weeks
Diabetic Foot Care Self-Efficacy Scale
Time frame: at 12 weeks
Medication Adherence Report Scale
Time frame: at 1 week
Medication Adherence Report Scale
Time frame: at 8 weeks
Medication Adherence Report Scale
Time frame: at 12 weeks
Watson Patient Satisfaction Assessment Form According to Healing Processes
Time frame: at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watson's human care theory-based motivational interviewing method in people with Foot Ulcer, Diabetic, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wagner's ulcer classification scale (time frame: at 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.